Early Follicular Supplementation of Ganirelix in IVF 2004

NCT ID: NCT00461422

Last Updated: 2008-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-06-30

Brief Summary

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Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results

Detailed Description

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GnRH antagonist offers many advantages when used in IVF-ET treatment, however, it is suspected to yield lower pregnancy rate when compared with the long GnRH agonist protocol.

Our goal was to investigate whether early follicular supplementation of the GnRH antagonist to the flexible GnRH antagonist protocol, has a potential to improve IVF-ET clinical results.

Consecutive patients are prospectively enrolled and randomly assigned to the study and control groups. Patients with low ovarian reserve or with uterine distortion are excluded from the study. Both groups are treated with recombinant FSH and the flexible GnRH antagonist protocol. Women in the study group are also treated with additional GnRH antagonist 0.25 mg/day on day 1, 2 and 3 of the menstrual cycle.

Conditions

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Infertility IVF Treatment

Keywords

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IVF GnRH antagonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard Flexible antagonist protocol Addition of Ganirelix at first 3 days of the cycle

Group Type EXPERIMENTAL

Ganirelix

Intervention Type DRUG

sc injection of Ganirelix 0.25 mg per day

2

Standard Flexible antagonist protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ganirelix

sc injection of Ganirelix 0.25 mg per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* infertility
* IVF candidate
* failure of previous IVF attempt

Exclusion Criteria

* low ovarian reserve
* untreated distortion of uterine cavity
* medical contraindication for IVF treatment
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Organon

INDUSTRY

Sponsor Role collaborator

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Yohnny S Younis, MD

Role: PRINCIPAL_INVESTIGATOR

The Ministry of Health, Israel

Locations

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The Baruch Padeh medical center, Poriya

Tiberias, , Israel

Site Status

Countries

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Israel

Other Identifiers

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soltsman2004.CTIL

Identifier Type: -

Identifier Source: org_study_id